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Taking people in ItalyNo phase

Studies ravulizumab early in antibody-positive generalized myasthenia gravis

Observes ravulizumab use in adults with early antibody-positive generalized myasthenia gravis.

Key facts

Who runs it
Alexion Pharmaceuticals, Inc.
Where
Bergamo, Bologna, Brescia, Florence, Imperia, Lecco, Messina, Milan, Naples, Novara, Orbassano, Padova, Palermo, Parma, Pavia, Pisa, Roma, Salerno, San Giovanni Rotondo, Sassari, and Torino, ItalySee the 21 sites
Trial code
Registry title
Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
Status
Recruiting
People taking part
40 people, planned
Started
31 Jul 2025
Expected to end
30 Jun 2027
Type of study
Observational
Treatments tested
  • Ravulizumab
Record updated
5 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with generalized myasthenia gravis who test positive for anti-AChR antibodies, whose disease began no more than 3 years ago, and who are getting Ravulizumab.

Age
18 years and older
Sex
All sexes can join.
Disease stage
Generalized myasthenia gravis, MGFA class IIb to IV, with disease duration of 3 years or less from onset.
Earlier treatment
Must not have had earlier treatment with C5 inhibitors. Last rituximab infusion must be at least 6 months before enrolment. Last FcRn blocker infusion must be at least 3 months before enrolment. Meningococcal vaccination must be completed at least two weeks before Ravulizumab, or antibiotic prevention used.
Biomarker or test result
A history of a positive blood test for anti-AChR antibodies, plus a confirming test result or improvement on cholinesterase inhibitor pills.

Main reasons for not taking part

  • Earlier treatment with C5 inhibitors
  • Rituximab infusion less than 6 months before enrolment
  • FcRn blocker infusion less than 3 months before enrolment
  • Pregnant, breastfeeding or planning a pregnancy during the study
  • Past or current participation in other interventional studies

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Diagnosis of MG confirmed by:; History of a positive serologic test for anti-AChR antibodies, and; One of the following:; History of abnormal neuromuscular transmission test demonstrated by singlefibre electromyography or repetitive nerve stimulation; History of positive anticholinesterase test (e.g., edrophonium chloride test); or; Patient demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician
  • Disease duration from MG onset ≤ 3 years before T-4 (Enrolment)
  • MGFA class IIb to IV
  • Patient eligible for Ravulizumab treatment based on AIFA reimbursement criteria
  • Vaccination cycle for Neisseria meningitidis completed at least two weeks before Ravulizumab initiation or antibiotics chemoprophylaxis according to the SmPC

Who cannot take part

  • Previous treatment with C5 inhibitors
  • Last rituximab infusion performed < 6 months before T-4 (Enrolment)
  • Last infusion with FcRn blockers performed < 3 months before T-4 (Enrollment)
  • Previous or current participation to other interventional studies
  • Hypersensitivity to the active substance or to any of the excipients of the study product
  • Patient unable to understand and sign the informed consent
  • Patient for whom the study product is contraindicated according to SmPC
  • Pregnant or lactating or planning a pregnancy during the study
  • Patient who plan to relocate during the study
  • Patient who are unsure of following the visit schedule
  • Patient unable to complete questionnaires

Where in Italy

  • Bergamo, LombardyHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Taking people
  • Bologna, Emilia-RomagnaHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • BresciaHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Taking people
  • FlorenceHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Taking people
  • ImperiaHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • LeccoHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Taking people
  • MessinaHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • Milan, LombardyHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Taking people
  • Naples, CampaniaHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • NovaraHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • OrbassanoHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • PadovaHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • PalermoHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • ParmaHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Taking people
  • PaviaHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • Pisa, TuscanyHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • RomaHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • SalernoHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting
  • San Giovanni RotondoHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Taking people
  • SassariHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Taking people
  • TorinoHospital not named in the registryContact: Alexion Pharmaceuticals, Inc. (Sponsor)Not yet recruiting

About the trial

What the trial wants to find out

The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population.

The group in the trial

  • Ravulizumab

    Participants will receive Ravulizumab until Week 50 ± 14 days after baseline or until discontinuation.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
MG-EVOLUTION. Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis: A Real-World Study With Biomarker Analysis
Plain-language title
Studies ravulizumab early in antibody-positive generalized myasthenia gravisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
5 February 2026